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Trial record 1 of 1 for:    NCT03616158
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Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time (RA-LD)

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ClinicalTrials.gov Identifier: NCT03616158
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : June 6, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
National Jewish Health

Tracking Information
First Submitted Date July 31, 2018
First Posted Date August 6, 2018
Last Update Posted Date June 6, 2019
Actual Study Start Date May 10, 2018
Estimated Primary Completion Date May 10, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 3, 2018)
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD). [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time
Official Title Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease
Brief Summary The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.
Detailed Description This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and sputum
Sampling Method Non-Probability Sample
Study Population Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.
Condition
  • Rheumatoid Arthritis
  • Lung Diseases
Intervention Not Provided
Study Groups/Cohorts
  • Pre-RA

    Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and positive antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

    In-person Study Assessments Include:

    1. Medical History and Physical Exams
    2. Quality of Life Questionnaires
    3. Collection of blood
    4. Radiology
    5. Lung Function Test
    6. 6 Minute Walk Test
    7. Bronchoscopy (Clinically indicated)
    8. Sputum (Optional)
    9. Musculoskeletal ultrasound (Optional)
  • RA without LD

    Subjects with rheumatoid arthritis (RA), and no interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

    In-person Study Assessments Include:

    1. Medical History and Physical Exams
    2. Quality of Life Questionnaires
    3. Collection of blood
    4. Radiology
    5. Lung Function Test
    6. 6 Minute Walk Test
    7. Bronchoscopy (Clinically indicated)
    8. Sputum (Optional)
    9. Musculoskeletal ultrasound (Optional)
  • RA-LD

    Subjects with rheumatoid arthritis (RA) and interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

    In-person Study Assessments Include:

    1. Medical History and Physical Exams
    2. Quality of Life Questionnaires
    3. Collection of blood
    4. Radiology
    5. Lung Function Test
    6. 6 Minute Walk Test
    7. Bronchoscopy (Clinically indicated)
    8. Sputum (Optional)
    9. Musculoskeletal ultrasound (Optional)
  • LD Controls

    Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and negative antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

    In-person Study Assessments Include:

    1. Medical History and Physical Exams
    2. Quality of Life Questionnaires
    3. Collection of blood
    4. Radiology
    5. Lung Function Test
    6. 6 Minute Walk Test
    7. Bronchoscopy (Clinically indicated)
    8. Sputum (Optional)
    9. Musculoskeletal ultrasound (Optional)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 5, 2019)
340
Original Estimated Enrollment
 (submitted: August 3, 2018)
420
Estimated Study Completion Date December 1, 2024
Estimated Primary Completion Date May 10, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

1. Age 18 - 80 years

Exclusion Criteria:

  1. Subjects who do not speak English
  2. Subjects without the capacity to sign the informed consent form (ICF)
  3. Pregnant women
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Faduma Ahmed, MPH 303-398-1285 ahmedf@NJHealth.org
Contact: Jami Henriksen 303-398-1233 henriksenj@NJHealth.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03616158
Other Study ID Numbers HS-3161
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Jewish Health
Study Sponsor National Jewish Health
Collaborators Pfizer
Investigators
Principal Investigator: Joshua Solomon, MD National Jewish Health
PRS Account National Jewish Health
Verification Date June 2019